Evaluation and Comparison of Systemic Exposure to Ibuprofen After Single Oromucosal Versus Oral Administrations

• Status: Completed
• Trial end date: 2013-06-01
• Target enrollment: 0
• Participant gender: Male

Summary

The purpose of this study is to evaluate the systemic exposure to ibuprofen after single oromucosal administration of the test product V0498 and single oral administration of a reference product.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Pierre Fabre Medicament
• Treatments: Ibuprofen

Criteria

Inclusion Criteria:

• Healthy male subject aged 18 to 45 years (inclusive),

• 18.5 < or = Body Mass Index < or = 30 kg/m²,

• Non-smoker for at least 6 months

• Subject agreed to be registered in the Belgium national register "VIP Check International" for this study participation .

Exclusion Criteria:

• Positive serology for Hepatitis B Virus antigens, Hepatitis C Virus or Human Immunodeficiency Virus 1 or 2 antibodies,

• Organic disorder likely to modify absorption, distribution or elimination of the medication,

• History of sensitivity to ibuprofen or other NonSteroidal Anti-Inflammatory Drugs (NSAIDs) or to any of the excipients

• Subject who has donated blood within the past 3 months,

• Subject who has forfeited his freedom by administrative or legal award, or who is under guardianship or who has been admitted in a sanitary or social institution,

• Participation in another clinical trial in the previous month or subject still within the exclusion period of a previous clinical trial or is participating in another clinical trial,